Responsible for leading and executing global regulatory submissions and compliance activities for our innovative portfolio of ultrasound, AI-enabled imaging, CT, and digital X-ray medical devices.

Bachelor’s in Regulatory, Engineering or related field preferred
5+ years of related experience in regulatory affairs
Proven track record of authoring successful submissions of FDA 510(k)s
CE Marking and other international registrations
Post-market regulations and requirements for medical devices
Working with devices involving CT, X-Ray and Ultrasound.
Regulatory Affairs Certification (RAC) preferred.
Strong knowledge of international medical device regulations (FDA, Health Canada, ANVISA, NMPA, CDSCO, TGA)
Familiarity with AI/ML regulatory frameworks, cybersecurity and usability standards
Ability to communicate effectively with engineers, marketing, and management through all media
Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines
Technically savvy; must be able to discuss, understand and author presentations, documentation and reports
Excellent written, oral, and documentation skills
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire

4 Different Blue Cross/Blue Shield Medical Plans to meet your needs
Dental coverage through BlueCross/Blue Shield Dental
Vision coverage by Blue Cross/Blue Shield
Company paid Short-term and Long-term Disability coverage
$1 for $1 401k match up to 5% managed by Fidelity
Other benefit options such as company paid employee life insurance, a wellness program, tuition reimbursement and many more!

Senior Regulatory Affairs Specialist

Key skills